Photocure ASA · OSL:PHO
Photocure ASA — Investor Presentation (March 2011)
46 slides from Photocure ASA's investor presentation, Mar 28, 2011
Slide 1: Photocure ASA
Brilliance in photodynamic technology Photocure ASA The world leader in photodynamic technology March 28, 2011 Kjetil Hestdal, CEO
Slide 2: Disclaimer
Disclaimer The information included in this Presentation contains certain forward-looking statements that address activities, events or developments that Photocure ASA (“the Company”) expects, projects, believes or anticipates will or may occur in the future. These statements are based on various as
Slide 3: Photocure Technology Platform
Photocure Technology™ Platform • Innovative & proven – multiple applications • Strong IP base • Established & well known treatment in dermatology • Enables earlier & more accurate diagnosis and treatment of cancer • Few/ limited side effects 3
Slide 4: Significant Milestones Achieved
Significant Milestones Achieved Lumacan 1st marketing approval for Licensed Hexvix to Salix Metvix approved in EU, launched Metvix/Aktilite Start of Metvix Metvix licensing Galderma’s 1st approved in Cysview in Nordic clinical trials agreement with Metvix launch the USA approved in region Galderma U
Slide 5: Focused Strategy
Focused Strategy Photocure’s strategy is to build a specialty pharma company: • Maximise the potential of the Photodynamic Technology Platform • Develop, register & commercialise new products in Dermatology & Cancer • Dermatology • Develop own PDT-based products Focus on Allumera™ and Visonac® • Est
Slide 6: Hexvix/Cysview
Hexvix®/CysviewTM Improved detection of bladder cancer • First approved drug-device procedure for bladder cancer • Improvement in patient detection rates by 30% - enabling doctors to remove tumours more effectively (TURB, TransUrethral Resection of the Bladder) • Volume growth of 31% in 2010 – led b
Slide 7: Cevira
Cevira® Treatment of HPV & pre-cancerous lesions in cervix • Offering effctive non-surgical treatment. • Simple to use, quick and non-invasive procedure • Preserves normal tissue • Improved device, worn internally, disposed of by the patient • Increased pasient comfort, less traumatic therapeutic ex
Slide 8: Lumacan
Lumacan® Improved detection of Colorectal Cancer • Lumacan licenced to Salix in October 2010 • Exclusive worldwide license - excluding the Nordic region • Development, registration and commercialisation • Signing fee of USD 4 million and milestone payments of up to USD 126.5 million • Royalties on n
Slide 9: Creating Value - Strong IP Position
Creating Value - Strong IP Position Clinical pipeline: Pre- Indication Phase I Phase II Phase III Market Status Clinical Detection of Hexvix® Marketed in Europe and US bladder cancer CANCER Treatment of Cevira® precursors of Phase II cervical cancer Detection of Lumacan® Licensed to Salix colon canc
Slide 10: Next Major Milestones
Next Major Milestones Commercial: • GE Healthcare launch of Cysview in the US • Progress on commercial activities for Hexvix in Europe • Prepare for first dermatology product launch in the US in Q2 2011 Pipeline progress: • Visonac: Starting phase IIb study in Q2 2011 • Cevira: Starting phase II in
Slide 11: Lumacan
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Slide 12: Lumacan
Lumacan Lumacan [hexaminolevulinate (HAL)] is used for fluorescence imaging of the colon in combination with blue light colonoscopy Currently in early stage clinical development for use as an enhanced diagnostic tool in patients referred for diagnostic and surveillance colonoscopy Lumacan gene
Slide 13: Lumacan: Morphology and Metabolism
Lumacan: Morphology and Metabolism HAL enters the cell by passive diffusion and is metabolized to Photoactive Porphyrins (PAP) The higher metabolic rate of tumor cells compared with normal tissue results in higher levels of PAP, allowing detection Glycine ALA ALA HAL + Succinyl CoA Heme Porphobi
Slide 14: Lumacan: Product Attributes
Lumacan: Product Attributes Efficacy – In an proof-of-concept study in patients with rectal cancer, administration of Lumacan by enema followed by blue light inspection induced selective fluorescence of adenomas, even in small lesions – Lumacan revealed ~ 65% more adenomas than white light inspect
Slide 15: Lumacan Oral Formulation Clinical Development Timeline
Lumacan Oral Formulation Clinical Development Timeline Formulation development Phase 1 Phase 2 Phase 3 2011 2012 2013 2014 2015 2016 • NDA submission anticipated: 2016 • US approval anticipated: 2017 15
Slide 16: U.S. Colon Cancer Market
U.S. Colon Cancer Market Incidence – An estimated 142,570 people were diagnosed with CRC in 20101 – In 2009, the impact of new CRC cases alone was estimated at $15.7B2 – CRC remains predominantly an illness for which the risk increases with age1 • Over 70% of patients are diagnosed between the age
Slide 17: U.S. Market Opportunity
U.S. Market Opportunity Excluding skin cancers, CRC is the third most common diagnosed cancer among men and women1 An estimated 15M colonoscopy procedures are performed annually2 Target patient segments (account for over 50% of all the CRC related colonoscopies in the US) – Screening of “high
Slide 18: U.S. Market Opportunity (cont.)
U.S. Market Opportunity (cont.) Experts agree there is a high level of need for an enhanced diagnostic technique for detecting smaller adenomas and flat lesions that may be missed using conventional white light colonoscopy – 50% of interval cancers likely result from the missed lesions during colo
Slide 19: One Tract
Advancing Treatment In Gastrointestinal Disorders We have a One Tract mind. 19
Slide 20: Forward-Looking Statement
Forward-Looking Statement Statements presented in this overview that are not historical facts are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from projected results. Factors that could cause actual results to differ materially
Slide 21: Mission Statement
Mission Statement Salix Pharmaceuticals is committed to being the leading U.S. specialty pharmaceutical company licensing, developing and marketing innovative products to healthcare professionals to prevent or treat gastrointestinal disorders. 21
Slide 22: Experience
Experience Proven track record of acquiring products -16 products since inception Success in progressing product candidates through late-stage development and FDA approval process - 7 NDAs approvals and new product launches since 2000 - 2 NDAs pending approval Specialty sales force - Average 1
Slide 23: History of Success
History of Success 2000–2003 2004–2006 2007–2009 2010–2011 Acquisitions Budesonide Foam Lumacan Crofelemer & In-licenses NDA Approvals Product Launches 23
Slide 24: Commercial Overview
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Slide 25: Current Run Rates (annualizing January 2011 TRx)
Current Run Rates (annualizing January 2011 TRx) $312 Product sales in millions/year $101m $50m $13m XIFAXAN Bowel APRISO Other Cleansing 25
Slide 26: Xifaxan
Unique, Gastrointestinal-Specific Antibiotic – “Works in the gut and only in the gut” – No stable resistance – Reduced risks – Broad spectrum 2004 FDA approval for Travelers’ Diarrhea 2010 FDA approval for Hepatic Encephalopathy 49% mg unit growth (2010 vs. 2009) 7.42 billion mg prescribed
Slide 27: Rifaximin in NEJM
Rifaximin in NEJM Rifaximin Treatment in Hepatic Encephalopathy a Rifaximin Therapy for Patients with Irritable Bowel Syndrome without Constipation ABSTRACT Salix® 27
Slide 28: Bowel Cleansing
Bowel Cleansing • - Only 2-L liquid PEG with ascorbic acid - #1 prescribed branded purgative worldwide - #1 prescribed branded purgative by U.S. gastroenterologists and colorectal surgeons • - Only tablet formulation Growing Market - $700 million potential market - Approx.14 million bowel cleans
Slide 29: MoviPrep TRx Count Since Launch
MoviPrep TRx Count Since Launch Source Data: WK PHAST Monthly Retail & Mail Order and PHAST Monthly Non Retail 29
Slide 30: Inflammatory Bowel Disease
Inflammatory Bowel Disease • For maintenance of remission of ulcerative colitis First and only 5-ASA with delayed- and extended-release delivery Once daily dosing for 24-hour protection Revenue Target: exceed $100 million (Peak Year) 30
Slide 31: Apriso Quarterly TRx Count
Apriso Quarterly TRx Count 70 000 Total Converted TRx Count 60 000 50 000 40 000 30 000 20 000 10 000 0 Q1 2009 Q2 2009 Q3 2009 Q4 2009 Q1 2010 Q2 2010 Q3 2010 Q4 2010 Source: Wolters Klewer 31
Slide 32: Product Development Overview
Product Development Overview 32
Slide 33: Pipeline
Pipeline Clinical Phases Program Indication Phase 2 Phase 3 NDA Review Crofelemer HIV-associated diarrhea Relistor SI OIC in chronic pain Relistor Oral OIC in chronic pain Budesonide Ulcerative proctitis or Foam proctosigmoiditis Assist in detection of Lumacan precancerous and cancerous In developme
Slide 34: Crofelemer Outlook
Crofelemer Outlook Indication – Treatment of chronic diarrhea in people living with HIV, or HIV-associated diarrhea Phase 3 Top-Line Results – Crofelemer provided relief of diarrhea for a highly statistically significant proportion of patients compared to placebo Market Opportunity – 1.2 milli
Slide 35: Relistor
Relistor Indication – RELISTOR (methylnaltrexone bromide) Subcutaneous Injection is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Use of RELISTOR beyon
Slide 36: Relistor
Relistor Market Opportunity – First-in-class treatment for OIC – Approved in 50 countries, launched in 30 countries worldwide – U.S. Market Size (# patients) • 1 million: Advanced illness • 10 million: Chronic pain Revenue Target: $1 billion (Peak Year) 36
Slide 37: Budesonide Foam Outlook
Budesonide Foam Outlook Indication – Treatment of mild to moderate ulcerative proctitis or proctosigmoiditis Status – Phase 3 underway Market Opportunity – ~2.5 million rectal prescriptions annually (2010) • ~550k written by GEs (2010) – First and only budesonide foam on the market, if approve
Slide 38: Capitalization (in millions)
Capitalization (in millions) December 31, 2010 Cash, cash equivalents, investments $518.0 Long-term debt $405.0 Common shares outstanding 58.0 Fully diluted common shares, if 65.6 profitable (Treasury Method) 38
Slide 39: Sustained Revenue Growth
Sustained Revenue Growth (Management estimate) 39
Slide 40: Value Proposition
Value Proposition Growing base business Numerous pipeline opportunities in areas with significant unmet medical needs addressing large dollar markets Strong patent portfolio Leading to $1 billion in revenue in the next 3 years 40
Slide 41: Lumacan
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Slide 42: Lumacan
Lumacan Target Product Profile – Fluorescing Rx agent (and associated colonoscope/filter) to improve the detection of precancerous and cancerous lesions in the colon Status – Oral formulation in development Market Opportunity – 15 million U.S. colonoscopies annually – Fluorescence (“blue-light
Slide 43: Salix Sales Force
Salix Sales Force Salix Sales Resources – 160 Territory Managers and 6 Telesales representatives • Targeting over 20,000 Health Care Providers: Gastroenterologists, Internal Medicine, Colorectal Surgeons, Nurse Practitioners, & Physician Assistants – 25 Key Account Managers (KAMs) • Targeting over
Slide 44: Marketing and Sales Opportunities
Marketing and Sales Opportunities Medical Publications/Communications Submissions and Advertising – American Journal of Gastroenterology (AJG), Gastroenterology, Gastrointestinal Endoscopy (GIE), Gastroenterology & Endoscopy News, Clinical Gastroenterology and Hepatology, Journal of American Medic
Slide 45: Marketing and Sales Opportunities
Marketing and Sales Opportunities Medical Conference Attendance – Society of Gastroenterology Nurses and Associates (SGNA), Digestive Disease Week (DDW), American Society of Colon and Rectal Surgeons (ASCRS), American Academy of Physician Assistants (AAPA), American Academy of Nurse Practitioners
Slide 46: Marketing and Sales Opportunities
Marketing and Sales Opportunities Advisory Meetings – Steering Committee Meetings • An R&D Steering Committee Meeting is scheduled to coincide with DDW in May 2011 – Advisory Board Dinner Series – Consultant Meetings Market Research – Primary and Secondary Market Research (Quantitative and Quali